PEDMARK

Peak

sodium thiosulfate

NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Sep 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
6

Mechanism of Action

Cisplatin-induced ototoxicity is caused by irreversible damage to hair cells in the cochlea hypothesized to be due to a combination of reactive oxygen species (ROS) production and direct alkylation of DNA leading to cell death. Sodium thiosulfate interacts directly with cisplatin to produce an…

Clinical Trials (5)

NCT04983238Phase 1/2Completed

Evaluation of Safety and Efficacy of Sodium Thiosulfate (BYON5667) Eye Drops to Reduce Ocular Toxicity in Cancer Patients Treated With SYD985

Started Jan 2022
NCT00983398Phase 1/2Unknown

Melphalan, Carboplatin, Mannitol, and Sodium Thiosulfate in Treating Patients With Recurrent or Progressive CNS Embryonal or Germ Cell Tumors

Started Jul 2009
17 enrolled
Central Nervous System Embryonal NeoplasmEmbryonal Tumor With Multilayered Rosettes, C19MC-AlteredGerm Cell Tumor+7 more
NCT00568399N/ACompleted

Sodium Thiosulfate Treatment of Vascular Calcification in ESRD

Started Dec 2007
48 enrolled
Complication of HemodialysisCardiovascular Diseases
NCT00303849Phase 1/2Completed

Carboplatin, Melphalan, Etoposide Phosphate, Mannitol, and Sodium Thiosulfate in Treating Patients With Previously Treated Brain Tumors

Started Sep 2005
33 enrolled
Anaplastic OligoastrocytomaAnaplastic OligodendrogliomaMixed Glioma+1 more
NCT00238173Phase 1Terminated

Acetylcysteine, Mannitol, Combination Chemotherapy, and Sodium Thiosulfate in Treating Children With Malignant Brain Tumors

Started Dec 2004
2 enrolled
Bone Marrow SuppressionBrain and Central Nervous System TumorsDrug/Agent Toxicity by Tissue/Organ+1 more

Loss of Exclusivity

LOE Date
Jul 1, 2039
162 months away
Patent Expiry
Jul 1, 2039
Exclusivity Expiry
Sep 20, 2029

Patent Records (5)

Patent #ExpiryTypeUse Code
10596190
Jan 5, 2038
U-3443
11291728
Jul 1, 2039
Product
11510984
Jul 1, 2039
Product
11617793
Jul 1, 2039
Product
11964018
Jul 1, 2039
U-3898